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Monday, 04/12/2010 11:16:50 AM

Monday, April 12, 2010 11:16:50 AM

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PR 4-12-10: Peregrine Launches IST Cancer Program for Bavi & Cotara

Peregrine Launches Investigator-Sponsored Trial Program
• New Program Supports Investigator Requests to Conduct Trials With Peregrine's Bavituximab or Cotara(R) Clinical Products
• IST Program Complements Peregrine's Ongoing Phase II Clinical Programs
http://ir.peregrineinc.com/releasedetail.cfm?ReleaseID=458089

TUSTIN, Apr 12, 2010: Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical company developing first-in-class phosphatidylserine (PS)-targeting monoclonal antibodies for the treatment of cancer and viral infections, today announced the launch of an investigator-sponsored trial (IST) program for bavituximab and Cotara(R). Bavituximab is a novel approach to treating cancer and viral infections and has demonstrated promising interim results in ongoing Phase II clinical trials in non-small cell lung cancer (NSCLC) and advanced breast cancer. Cotara is a brain cancer therapy currently in a Phase II clinical trial for recurrent glioblastoma multiforme (GBM), and has generated promising survival data in earlier studies.

"Even before formally announcing our IST program, we have been receiving an increasing number of requests from investigators interested in conducting clinical studies with either bavituximab or Cotara, and we are eager to evaluate proposals and begin working with investigators to start new clinical studies," commented Marvin R. Garovoy, M.D., head of clinical science at Peregrine. "The launch of our new IST program comes as we prepare to present additional data from multiple clinical studies at upcoming conferences and provide updates to the oncology community. We believe our IST program can provide valuable information on mechanisms of action, use in additional oncology indications, and application in different therapeutic combinations, and we welcome the opportunity to offer this program to oncologists who share our excitement over the clinical potential of our novel agents."

This program offers oncologists the opportunity to conduct clinical trials for Cotara in brain cancer and bavituximab in the following indications:
-- Breast cancer
-- Fibrosarcoma
-- Brain cancer
-- Hodgkin's lymphoma
-- Non-small cell lung cancer
-- Pancreatic cancer
-- Prostate cancer
-- Colorectal cancer
-- Melanoma
-- Renal cancer
-- Urinary bladder cancer
-- Hepatocellular carcinoma
-- Ovarian cancer

To apply for Peregrine's IST program, please visit http://www.peregrineinc.com/index.php?option=com_content&task=view&id=91 .

"As we prepare to initiate two new randomized Phase II trials of bavituximab in NSCLC patients, the data from our IST collaborations will provide additional insight into our agents' mechanisms of action, augment our safety database, and evaluate new combination therapy approaches to treating cancer and HCV patients with our PS-targeting antibodies," commented Joseph Shan, M.P.H., VP of clinical and regulatory affairs at Peregrine. "Interim data reported to date in our bavituximab and Cotara trials have been promising and we look forward to working with our IST collaborators to advance the clinical study of our novel agents for serious unmet medical needs for cancer patients."

Peregrine's most advanced PS-targeting antibody bavituximab is currently in multiple Phase II clinical trials for non-small cell lung cancer (NSCLC) and advanced breast cancer (ABC), with interim results showing:
-- 52% (11 of 21) of the initial cohort of NSCLC patients treated with
bavituximab in combination with carboplatin/paclitaxel achieved an
objective response. Median progression-free survival (PFS) of the
initial cohort was 6.5 months.
-- 61% (28 of 46) of ABC patients treated with bavituximab in combination
with docetaxel achieved an objective response, with the initial cohort
of 15 patients demonstrating a median PFS of 7.4 months.
-- 60% (9 of 15) of the initial cohort of ABC patients treated with
bavituximab in combination with carboplatin/paclitaxel achieved an
objective response.

In multiple preclinical studies, bavituximab has shown encouraging efficacy in models of breast, prostate, and pancreatic cancer. Bavituximab has been shown to induce multiple immunomodulatory mechanisms, including anti-tumor effects in helping the immune system fight cancer. Peregrine's Cotara has been administered to a total of 125 patients with brain, colon or liver cancer, showing promising survival data in early studies.

ABOUT BAVITUXIMAB
Peregrine's lead phosphatidylserine (PS)-targeting antibody is bavituximab, a first-in-class monoclonal antibody that targets the cellular membrane phospholipid PS. Usually located inside cells, PS becomes exposed on the outside of cells that line tumor blood vessels and on certain viruses and the cells they infect, creating a specific target for treatments while sparing healthy cells that do not express PS. Bavituximab induces immune cell-mediated destruction of cells with exposed PS and is also believed to restore the immune system's ability to recognize and respond by blocking PS-mediated immunosuppression. Initial results from Phase II cancer trials of bavituximab in combination with chemotherapy have been encouraging, with objective tumor response rates that compare favorably to historical results with chemotherapy alone.

ABOUT COTARA
Cotara is an experimental treatment for brain cancer that links a radioactive isotope to a targeted monoclonal antibody designed to bind to the DNA histone complex that is exposed by dead and dying cells found at the center of solid tumors. Cotara's targeting mechanism enables it to bind to the dying tumor cells, delivering its radioactive payload to the adjacent living tumor cells and essentially destroying the tumor from the inside out, with minimal radiation exposure to healthy tissue. Cotara is delivered using convection-enhanced delivery (CED) that targets the specific tumor site in the brain. In brain cancer studies, Cotara has demonstrated encouraging patient survival data and a Phase II GBM trial is currently ongoing. Cotara has been granted orphan drug status and fast track designation for the treatment of GMB and anaplastic astrocytoma by the U.S. Food and Drug Administration.

ABOUT PEREGRINE PHARMACEUTICALS
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials for the treatment of cancer and serious viral infections. The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara(R). Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. ( http://www.avidbio.com ), which provides development and biomanufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com .
Safe Harbor *snip*

= = = = = = = = = = IST Page added 4-12-10 to Website:

Investigator Sponsored Trial (IST) Program
http://www.peregrineinc.com/index.php?option=com_content&task=view&id=91
We welcome the opportunity to work with clinical researchers who share our excitement in studying bavituximab, a first-in-class PS-targeting antibody currently in multiple clinical trials for oncology and viral diseases, and Cotara®, our novel approach to treating brain cancer.

This program offers oncologists the opportunity to conduct clinical trials for Cotara in brain cancer and bavituximab in the following indications:
• Breast cancer
• Fibrosarcoma
• Brain cancer
• Hodgkin's lymphoma
• Non-small cell lung cancer
• Pancreatic cancer
• Prostate cancer
• Colorectal cancer
• Melanoma
• Renal cancer
• Urinary bladder cancer
• Hepatocellular carcinoma
• Ovarian cancer
Click here to download an application to join the growing number of researchers interested in our IST program. If you have additional questions, please contact Marvin R. Garovoy, M.D. at 714-508-6032 or Edyta Walterska at 714-508-6025.

Peregrine's most advanced PS-targeting antibody bavituximab is currently in multiple Phase II clinical trials for advanced breast cancer (ABC) and non-small cell lung cancer (NSCLC), with interim results showing:
•60% (9 of 15) of the initial cohort of ABC patients treated with bavituximab in combination with carboplatin/paclitaxel achieved an objective response.
•61% (28 of 46) of ABC patients treated with bavituximab in combination with docetaxel achieved an objective response, with the initial cohort of 15 patients demonstrating a median PFS of 7.4 months.
•52% (11 of 21) of the initial cohort of NSCLC patients treated with bavituximab in combination with carboplatin/paclitaxel achieved an objective response, with the 21-patient cohort demonstrating a median PFS of 6.5 months.

In multiple preclinical studies, bavituximab has shown encouraging efficacy in models of breast, prostate, and pancreatic cancer. Bavituximab has induced multiple immunomodulatory mechanisms, including anti-tumor effects in helping the immune system fight cancer. Cotara has generated promising survival data for brain cancer patients with glioblastoma multiforme (GBM) in early studies.
*end*

= = = = = = = = = = =Background:
1-11-10: DR. MARVIN GAROVOY (EX-XOMA VP) JOINS PPHM AS HEAD/CLIN.SCIENCE
http://tinyurl.com/yz4fwyv
Dr. Garovoy will have primary responsibility for establishing & supervising an Investigator-Sponsored Trials (IST) pgm, as well as expanding scientific outreach & assisting with clinical trial design for the Bavi & Cotara pgms.
…CEO SK: ”These ISTs can be a very important part of our overall clinical dev. pgm, potentially providing invaluable info. that might not otherwise be obtained from our company-initiated trials.”
…Dr. Garovoy, “Bavituximab is a promising new approach with broad potential for the treatment of solid cancers and other diseases. Based on the encouraging results seen in early clinical trials, I welcome the opportunity to collaborate with clinical researchers to establish the investigator-sponsored studies that will enhance our understanding of the clinical potential of this exciting new agent."

3-11-10 C.CALL: JOE SHAN (VP/CLIN.+REG. AFFAIRS) – CLINICAL TRIALS:
“…While lung cancer is our current focus, we believe bavituximab has broad-spectrum potential, so we are also planning to expand the bavi oncology program into new clinical indications, based on supportive preclinical data or outside clinical interest. Areas under consideration include pancreatic, prostate, brain, and liver cancers, just to name a few. To assist in these efforts, we recently announced the addition of Dr. Marvin Garovoy as Head of Clinical Science [ 1-11-10 http://tinyurl.com/yz4fwyv ], and we expect the combination of both company and Investigator Sponsored Trials (IST’s) to be initiated throughout the rest of this year.”
http://tinyurl.com/yl4befh

3-17-10, CEO STEVE KING, ROTH INVESTORS CONF./DANAPT-CA:
“Another addition was Marvin Garovoy this past January [ 1-11-10 http://tinyurl.com/yz4fwyv ] – he brings extensive experience in the design & conduct of clinical trials. We brought him on board to really beef up the team and to allow us to pursue addl. opportunities, such as Investigator Sponsored Studies (IST’s), which as we’ve gotten into the Ph.2 data, we now have people coming to us wanting to run addl. studies with our compound… In addition, we’re evaluating a fair number of other opportunities - in Breast Cancer, obviously we have good clinical data to-date. We’ve been approached about running trials in Pancreatic Cancer; Liver Cancer is another natural fit because of the tie-in with HCV; Colorectal Cancer, NSCLC, Ovarian Cancer – we’re basically getting requests, almost on a weekly basis now, for diff. trials that investigators would like to run. So, we’ll probably run a combination of some company-sponsored studies, in addition to the 2 big NSCLC studies, and Investigator-initiated studies.”
http://tinyurl.com/ye9v7jq


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